Announcement • Jun 16
Carvolix Announces Positive Three-Year Clinical Results for Kalios Adjustable Mitral Ring Carvolix announced positive long-term clinical results from a pivotal study with its mitral ring Kalios. The company previously reported the 1-year results from the Optimise II study on 20 patients treated with the Kalios™ adjustable mitral annuloplasty device in patients with both degenerative (58%) and functional (42%) mitral regurgitation (MR), including 6 patients who underwent peri-operative or later adjustment without cardiopulmonary bypass. As the cohort matures, follow-up is now available in 20 patients at 2 years and 15 patients who reached 3 years of follow-up. At 3 years, the results confirm both the safety and efficacy of the implant: No adverse events related to the device were reported up to 3 years; All evaluated patients have mitral regurgitation grade =2+ at 3 years which meet the primary endpoint of the study. Mitral regurgitation is evaluated by echocardiography with an independent core lab, confirming sustained long-term efficacy. The mitral valve leaflet coaptation length improved from 3.9 mm at baseline to 6.4 mm at 3 years, demonstrating significant and sustained improvement in structural valve function. These long-term results confirm and consolidate the previously reported 1-year interim data and continue to validate the value proposition of KaliosTM mitral ring. The analysis of the primary efficacy endpoint at 3 years of the adjustable mitral ring has been submitted to a peer-reviewed journal, and a related abstract is submitted for scientific communication. Kalios™ is the only mitral annuloplasty device that can be adjusted percutaneously to treat both residual and recurrent mitral insufficiency at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart operation. Carvolix estimates that Kalios™ would prevent repeat surgery for potentially 30-40% of patients within 5 years. The market for mitral valve repair surgery is estimated to be worth $1.5 billion in the US-Europe region, growing at 3.5% per year. The European Optimise II pivotal study on KaliosTM has been designed to assess the medical device’s safety and efficacy in the surgical treatment of mitral regurgitation with catheter-based adjustment. In September 2023, the Company presented interim data on 20 patients treated in five clinical centers in Europe after one year of implantation. After one year, none of the patients had mitral regurgitation >2+, which met the study’s primary objective. Up to 100 patients are to be enrolled to obtain 62 evaluable patients at 1 year. Treated patients will be followed for 5 years post-surgery. Primary endpoints are the success rate of annuloplasty surgery defined by absence of MR of grade >2 and the safety at 1 year. Major Estimate Revision • Jun 02
Consensus revenue estimates increase by 15% The consensus outlook for fiscal year 2026 has been updated. 2026 revenue forecast increased from €1.22m to €1.40m. EPS estimate unchanged from -€0.46 at last update. Medical Equipment industry in France expected to see average net income growth of 25% next year. Consensus price target of €4.93 unchanged from last update. Share price rose 8.5% to €3.33 over the past week. Announcement • May 27
Carvolix SA, Annual General Meeting, Jun 30, 2026 Carvolix SA, Annual General Meeting, Jun 30, 2026. Location: 900 rue andre ampere batiments a et c, aix en provence France 
